Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
NCT ID: NCT06170281
Last Updated: 2024-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-12-15
2025-12-31
Brief Summary
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Detailed Description
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* Choice Arm: allowed to choose from a menu of migraine behavioral treatment options
* Random: randomized to migraine behavioral treatment options.
After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Random - ME
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Random - MS
participants will be randomized to an intervention involving regular mealtime and regular sleep
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Random - SE
participants will be randomized to an intervention involving regular sleep and regular timed exercise
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Choice - ME
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Choice - MS
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Choice - SE
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Interventions
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Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Eligibility Criteria
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Inclusion Criteria
* aged 18 years and older
Exclusion Criteria
* children younger than 18 years old
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Stanford University
OTHER
Responsible Party
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Dr. Yohannes Woldeamanuel, MD
Instructor at Department of Neurology
Principal Investigators
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Yohannes W Woldeamanuel, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1.
Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25.
Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.
Other Identifiers
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70767
Identifier Type: -
Identifier Source: org_study_id
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